Hi
Hope you are doing well !!
This is Harish From USG.I
have an Urgent Requirement for Validation Analyst. I hope your resume fits
for the below position. Kindly let me know your interest and also required
your updated resume. Please feel free to reach me any time.
*Role *: Validation Analyst
*Location* : Allendale NJ
*Duration* : 6 months
*Experience: *6 Years +
*JD*
*Technical/Functional Skills*
Software Validation, Pharma
*Experience Required *
• Working experience in Validation projects is must. Experience in
writing Validation Plan, Validation Summary report and review of
SDLC/project deliverables is must. Person should have very good knowledge
of FDA regulations/GXP/21CFR Part 11
*Roles & Responsibilities*
• Ensures documentation and practices meet quality standards,
applicable regulatory compliance and IS guidelines/policies
• Review functional design specification, technical design
specifications for clarity, Good documentation practices.
• Review the accuracy and completeness of software validation
deliverables created by process work streams
• Knowledge of software testing. Ability to create Traceability
Matrices linking approved requirements to test cases within HPALM.
• Create validation deliverables like Requirements, Data Migration
Plan, Summary Reports, work instruction documents for tools
• Ability to pull necessary details from an object level Technical
Design Specs and Functional Design specs and consolidate the information in
a Master Technical and Functional Design document that is presentable to an
external regulatory agency.
• Experience working in an agile environment is preferre
Harish Karnala
United Software Group Inc..
565 Metro Place South. Suite # 110
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g>
Dublin, OH 43017
<https://maps.google.com/?q=565+Metro+Place+South.+Suite+%23+110++Dublin,+OH+43017&entry=gmail&source=g>
Direct Number : +1 614-408 1549
Board Number : 614-495-9222 EXT. 622
Fax: 1-866-764-1148
[email protected]
www.usgrpinc.com
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